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Atip EIS

by Shining 3D Tech Co., Ltd.

Ref 9959Model Aoralscan Elf Pro

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970163089959 UDI-DI Date15 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697016308AoralscanElfP7H Basic UDI-DI 06970163089959UDI-DIDate23 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Atip EIS EUDAMED
Shining 3D® GUDID
Generic Name
Dental milling system, CAD/CAM, chairside
Device Name
Intraoral Scanner
Model / Reference
Aoralscan Elf Pro EUDAMED
9959 EUDAMED
Atip EIS GUDID
Primary DI / UDI-DI
06970163089959
Basic UDI-DI
697016308AoralscanElfP7H
Direct Marketing DI
06970163089959
FDA Product Code
NOF
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental milling system, CAD/CAM, chairside
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3661
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Aoralscan Elf Pro
9959
GUDID
Atip EIS
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000008402
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shining 3D Tech Co., Ltd.

See all devices from Shining 3D Tech Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No